DyslipidemiaPhase 3NCT00361868
Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI
A Phase 3 study testing fenofibrate (F) + metformin (M) hydrochloride fixed combination and Rosiglitazone in people with Dyslipidemia and Glucose Metabolism Disorder, run by Solvay Pharmaceuticals at 70 sites in 8 countries.
Trial summary
Under conditions of first-line drug treatment in antidiabetic drug naïve/drug free patients with type 2 diabetes mellitus and dyslipidemia, to show that :- the efficacy of a fixed combination (FC) of fenofibrate and metformin on glycemic control is not inferior to that of rosiglitazone and the efficacy of FC of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyslipidemia, Glucose Metabolism Disorder
- What is being tested?
- fenofibrate (F) + metformin (M) hydrochloride fixed combination and Rosiglitazone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 70 sitesin 8 countries
- Study dates
- Jun 2006to Dec 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with Type 2 diabetes mellitus and dyslipidemia inadequately controlled with lifestyle modifications.
Who cannot join
- Type 1 diabetes.
Trial locations and contacts
70 sites in 8 countries.
70 sites in 8 countries
Germany14 sites
Site 405
Berlin
Site 410
Borna
Site 403
Bretten
Site 402
Dresden
Site 404
Frankfurt
Site 400
Freiburg im Breisgau
Site 401
Hanover
Site 409
Ilvesheim
Site 411
Ilvesheim
Site 407
Leipzig
Site 406
Rodgau
Site 413
Rotenburg (Wümme)
Site 408
Schwerin
Site 412
Villingen-Schwenningen
Poland12 sites
Site 610
Bialystok
Site 606
Elblag
Site 608
Gdansk
Site 600
Lodz
Site 605
Otolinska
Site 604
Radom
Site 613
Starogard Gdański
Site 601
Warsaw
Site 607
Warsaw
Site 612
Warsaw
Site 602
Wroclaw
Site 603
Wroclaw
Ukraine12 sites
Site 807
Kharkiv
Site 811
Kharkiv
Site 812
Kharkiv
Site 800
Kiev
Site 803
Kiev
Site 808
Kiev
Site 809
Kiev
Site 810
Kiev
Site 813
Kiev
Site 805
Lviv
Site 804
Odesa
Site 802
Vinnitsa
Netherlands9 sites
Site 509
Almere Stad
Site 502
Breda
Site 503
Eindhoven
Site 504
Groningen
Site 505
Leiden
Site 506
Nijmegen
Site 500
Rotterdam
Site 507
Velp
Site 508
Zoetermeer
France7 sites
Site 303
Bassens
Site 307
Bordeaux
Site 305
Mûrs-Erigné
Site 302
Seysses
Site 304
Strasbourg
Site 301
Thouars
Site 306
Vihiers
Croatia6 sites
Site105
Pula
Site102
Rijeka
Site103
Split
Site104
Varaždin
Site100
Zagreb
Site101
Zagreb
Romania6 sites
Site 704
Brasov
Site 701
Bucharest
Site 703
Bucharest
Site 700
Cluj-Napoca
Site 702
Iași
Site 705
Târgu Mureş
About this study
Official title: A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of a Fixed Combination of Fenofibrate and Metformin vs Rosiglitazone in Patients With Type 2 Diabetes Mellitus and Dyslipidemia
Under conditions of first-line drug treatment in antidiabetic drug naïve/drug free patients with type 2 diabetes mellitus and dyslipidemia, to show that :- the efficacy of a fixed combination (FC) of fenofibrate and metformin on glycemic control is not inferior to that of rosiglitazone and the efficacy of FC of fenofibrate and metformin on triglyceride control is superior to that of rosiglitazone.
- Conditions
- Dyslipidemia, Glucose Metabolism Disorder
- Being tested
- fenofibrate (F) + metformin (M) hydrochloride fixed combination, Rosiglitazone
- Keywords
- Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus
- Medical subject headings
- Dyslipidemias, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fenofibrate (F) + metformin (M) hydrochloride fixed combinationDrug
First period: F80mg/M500mg - per os - twice a day during 2 weeks and F80mg/M850mg - per os - twice a day during 10 weeks - Second period: F54mg/M850mg - per os - three times a day during 12 weeks
RosiglitazoneDrug
First period: 4 mg - per os - daily during 12 weeks - Second period: 4 mg - per os - twice a day during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination |
| 2 | Active comparator | Not described Receives: Drug: Rosiglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c/TG
Measured: 24 weeks
Secondary outcomes (1)
Lipid and glycemic parameters.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: The study was discontinued prematurely at the end of March 2007 due to slow enrolment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361868
- Sponsor's protocol ID
- C LF23-0121 05 01
- Other IDs
- 2005-006060-63, 2005
- Status last verified
- Jun 2008
- First submitted
- 8 Aug 2006
- Last updated
- 27 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of a Fixed Combination of Fenofibrate and Metformin vs Rosiglitazone in Patients With Type 2 Diabetes Mellitus and Dyslipidemia
- ClinicalTrials.gov ID
- NCT00361868
- Acronym / sponsor ID
- C LF23-0121 05 01
- Conditions
- Dyslipidemia, Glucose Metabolism Disorder
- Keywords
- Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was discontinued prematurely at the end of March 2007 due to slow enrolment.
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 9 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Under conditions of first-line drug treatment in antidiabetic drug naïve/drug free patients with type 2 diabetes mellitus and dyslipidemia, to show that :- the efficacy of a fixed combination (FC) of fenofibrate and metformin on glycemic control is not inferior to that of rosiglitazone and the efficacy of FC of fenofibrate and metformin on triglyceride control is superior to that of rosiglitazone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination |
| 2 | Active comparator | Drug: Rosiglitazone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with Type 2 diabetes mellitus and dyslipidemia inadequately controlled with lifestyle modifications.
Key exclusion criteria (1 listed)
- Type 1 diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fenofibrate (F) + metformin (M) hydrochloride fixed combinationFirst period: F80mg/M500mg - per os - twice a day during 2 weeks and F80mg/M850mg - per os - twice a day during 10 weeks - Second period: F54mg/M850mg - per os - three times a day during 12 weeks | Drug | 1 |
| RosiglitazoneFirst period: 4 mg - per os - daily during 12 weeks - Second period: 4 mg - per os - twice a day during 12 weeks | Drug | 2 |
Primary outcome
HbA1c/TG
Time frame: 24 weeks
1 secondary outcome
Lipid and glycemic parameters.
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: The study was discontinued prematurely at the end of March 2007 due to slow enrolment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2008.
Related trials for Dyslipidemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
70 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fenofibrate (F) + metformin (M) hydrochloride fixed combination and Rosiglitazone in people with Dyslipidemia and Glucose Metabolism Disorder, run by Solvay Pharmaceuticals at 70 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in Germany, Poland, Ukraine, Netherlands, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was discontinued prematurely at the end of March 2007 due to slow enrolment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c/TG (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2008.